check_circleStudy Completed
Hyperphosphatemia
Bayer Identifier:
15077
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Fosrenol post-marketing surveillance for hemodialysis in Japan
Trial purpose
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
3267Trial Dates
March 2009 - May 2019Phase
N/ACould I Receive a placebo
NoProducts
Fosrenol (Lanthanum Carbonate, BAY77-1931)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Incidence of adverse drug reactions in subjects who received Fosrenoldate_rangeTime Frame:After Fosrenol administration, up to 8 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Timing of onset of common ADRs related to the priority survey itemsThe items are - Gastrointestinal symptoms - Secondary hyperparathyroidism - Hypocalcaemia and decreased blood calciumdate_rangeTime Frame:After Fosrenol administration, up to 8 yearsenhanced_encryptionYesSafety Issue:
- Effect on bones: Alkaline phosphatase over timedate_rangeTime Frame:After Fosrenol administration, up to 8 yearsenhanced_encryptionNoSafety Issue:
- Effect on bones: Change in bone densitydate_rangeTime Frame:After Fosrenol administration, up to 8 yearsenhanced_encryptionNoSafety Issue:
- Cardiothoracic ratio over timedate_rangeTime Frame:After Fosrenol administration, up to 8 yearsenhanced_encryptionNoSafety Issue:
- PWV and ABI over timedate_rangeTime Frame:After Fosrenol administration, up to 8 yearsenhanced_encryptionNoSafety Issue:
- Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over timedate_rangeTime Frame:After Fosrenol administration, up to 8 years
- Percentage of patients achieving the serum P control goaldate_rangeTime Frame:After Fosrenol administration, up to 8 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A